PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 510

Inclusion Criteria

At Visit 1 (screening visit)
1.Signed written informed consent obtained before conduction of any trial related procedures
2.Age =18 years
3.CD symptoms/onset of disease: = 3 months prior Visit 1
4.Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
5.A confirmed diagnosis and location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy) at any time since the disease was diagnosed
6.A Harvey-Bradshaw score between 5 and 12
7.Males and non-pregnant, non-nursing women. Female patients should be post menopausal (women = 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception throughout the trial period.
8.Normal values of proteinuria and leucocyturia (=0/+)

At Visit 2 (randomisation visit)
9.Mild to moderate active CD, defined by a CDAI score between 180 and 350
10.Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g).
11.Haemoglobin value above 100 g/L
12.Values of aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatise (ALP), and/or bilirubin not more than 2 times upper limits of normal (ULN)
13.Estimated creatinine clearance should be above 75 ml/min.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At Visit 1 (screening visit)
1.Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient’s ability to participate in the trial
2.Ileostomy, ileo-pouch-anal anastomosis, ileorectal anastomosis, subtotal coloectomy and/or proctocoloectomy
3.Fistulas (external/internal and/or abscess)
4.Current or previous treatment for stricturing and penetrating disease (current strictures characterised by abdominal pain/cramping with radiologic/MRI/US stenosis with prestenotic dilatation or endoscopic stenosis not passable for the endoscope)
5.CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine.
6.CD isolated to colon below the left colon flexure and/or isolated proctitis and/or anal disease
7.Prior treatment resistance to mesalazine defined as no effect seen by treatment of active Crohn´s disease with = 4g daily for = 4 weeks
8.Unsuccessful treatment of current relapse (not applicable for newly diagnosed patients)
9.Hepatic (including sclerosing cholangitis) or renal functioning abnormalities
10.Documented histological gastrointestinal malignancy or high-grade dysplasia and/or other malignant disease (excluding basal and squamous skin cell carcinoma) within the last five years prior to entering the trial
11.Allergy to aspirin or salicylate derivatives
12.History of known hypersensitivity to the excipients used in the investigational medicinal products (IMPs)
13.Chronic, dominant arthralgia or Rheumatoid arthritis
14.Palpable abdominal mass
15.Participation in another clinical trial within the last 3 months prior to enrolment
16.Previous randomisation in the present trial
17.Biologics (e.g. anti-TNF-a) must not be used during the trial or 6 months before Visit 1
18.Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
19.Oral, rectal or i.v glucocorticosteroids must not be used during the trial or 2 weeks before Visit 1 (local treatments such as nasal sprays, inhalers and ointments are allowed at any time)
20.Immunomodulating/suppressing drugs (e.g. azathioprine, 6-mercaptopurine, cyclosporine, tacrolimus and methotrexate): must not be used during the trial or 3 months before Visit 1
21.Mesalazine, sulfasalazine and olsalazine compounds must not be used during the trial or 3 days before Visit 1
22.Continuous usage of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including salicylates must not be used (PRN/as needed use of NSAIDs, and treatment with low dose aspirin for prevention of cardiovascular diseases are allowed) during the trial or 2 weeks before Visit 1
23.Antibiotics: must not be used during the trial or 1 week before Visit 1
24.Intake of any kind of experimental treatment (e.g. cytokines, helminthics and probiotics) must not be used during the trial. Helminthics and cytokines must not be used 3 months before Visit 1
25.Patients must not have donated blood for 12 weeks prior to Visit 1

At Visit 2 (randomisation visit)
26.Stool culture showing unwanted pathogens such as: Salmonella, Shigella, Campylobacter and/or Clostridium difficile toxins
27.Patients who are unable to comply with the requirements of the protocol (e.g. alcohol or drug abuse, planned hospitalisation or any other condition associated with poor compliance)
28.Positive pregnancy test.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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